K190664 is an FDA 510(k) clearance for the RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on April 12, 2019, 28 days after receiving the submission on March 15, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K190664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2019 |
| Decision Date | April 12, 2019 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ — System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |